A Patient and Provider Intervention to Address Health Disparities in Lung Cancer Screening

Lung Cancer Clinical Trial

Official title:

A Multilevel Intervention to Address Health Disparities in Lung Cancer Screening

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04675476
• Other study ID #: STUDY00003277
• Status: Recruiting
• Phase: N/A
• Start date: February 19, 2024
• Est. completion date: February 28, 2026

Study information

• Verified date: September 2023
• Source: Georgetown University
• Contact: Randi M Williams, PhD
• Phone: (202) 687-7036
• Email: rmw27[@]georgetown.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To test the impact of a multilevel intervention on primary (provider-patient communication, intentions, and knowledge) and secondary (screening referrals and completion) outcomes.

Description:

The proposed study will target two key levels of influence in the healthcare setting: provider and patient behavior in order to address disparities between African American and whites in lung screening awareness and utilization. Guided by NIH's Health Disparities Research Framework and building on the formative work conducted in the K99 phase, we will conduct a quasi-experimental study (pretest-posttest, with a nonequivalent control group) in partnership with four primary care clinics within the MedStar Health system in the R00 phase.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 368
• Est. completion date: February 28, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

• 50-80 years old;

• current cigarette smoker or quit within 15 years;

• a 20+ pack-year smoking history;

• non-adherent to lung screening (>13 months);

• English-speaking;

• scheduled for an upcoming clinic appointment (4 weeks - 8 weeks); and

• able and willing to provide meaningful consent and complete telephone interviews

Exclusion Criteria:

• Individuals with a history of lung cancer

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Behavioral:
• Provider Prompt & Patient Outreach and Education
To target lack of provider-prompted discussion about lung screening, an electronic medical record (EMR) message will be sent to primary care providers prior to scheduled visits with screening-eligible patients to notify them of the patient's eligibility and to encourage discussion of the benefits and limitations of the test. To target patient-level knowledge about lung screening, an outreach specialist will educate screening-eligible patients about the benefits and limitations of the test prior to their visit.

Locations

Country	Name	City	State
United States	MedStar Health	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Georgetown University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	provider-patient discussion	Discussion about lung screening with the provider ('did you have a discussion with your doctor about lung screening?')	1-week post-visit
Primary	lung cancer screening intentions	Screening intentions ('how likely is it that you will undergo lung screening in the next 6-months?')	1-week post-visit
Primary	lung cancer screening knowledge	Lung cancer screening knowledge measure	1-week post-visit
Secondary	lung cancer screening referrals	Total number of lung screening orders captured via the electronic medical record	6-months
Secondary	lung cancer screening completion rates	Total number of lung screening completions captured via the electronic medical record	6-months